Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 6:31 PM
Ignite Modification Date: 2025-12-25 @ 4:02 PM
NCT ID: NCT00467857
Description: Investigators assessed patients for the occurrence of adverse events at each study visit and recorded in case report form. Device-related adverse events, surgical site infections, and death were the only types of adverse events collected.
Frequency Threshold: 0.5
Time Frame: 30 days
Study: NCT00467857
Study Brief: Study of the Combination of a Cyanoacrylate and Surgical Solutions in Reducing Skin Flora Contamination
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
InteguSeal* and Standard Surgical Preparation Solutions Prior to incision, surgical sites were prepared using InteguSeal\* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal\* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora. None None 6 146 6 146 View
Standard Surgical Preparation Solutions Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. None None 8 147 10 147 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Sudden death SYSTEMATIC_ASSESSMENT General disorders MedDRA (11.0) View
Incision site infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.0) View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.0) View
Mediastinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.0) View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.0) View
Hospitalisation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (11.0) View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA (11.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Mediastinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.0) View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.0) View
Postoperative wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.0) View
Skin graft infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.0) View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (11.0) View
Arteriovenous graft site infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.0) View
Incision site infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.0) View